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Boehringer Ingelheim to Present New Sub-Analyses of Pradaxa® (dabigatran etexilate mesylate) Bleeding Management and Outcomes at the ASH Annual Meeting and Exposition

RIDGEFIELD, Conn., Dec. 5, 2012 /PRNewswire/ -- Boehringer Ingelheim will present data from eight abstracts at the American Society of Hematology (ASH) Annual Meeting and Exposition in Atlanta, Ga., from December 8 to 11, 2012, including the results from a new sub-analysis of RE-LY® and four other Phase III dabigatran trials. These analyses reinforce BI's commitment to adding to the scientific body of data for PRADAXA.

Highlighted as "Best of ASH," the new sub-analysis of the RE-LY trial alone as well as part of a pooled sub-analysis of five Phase III studies in non-valvular atrial fibrillation (NVAF) and acute treatment and secondary prevention of venous thromboembolism, compared reports from major bleeding events associated with dabigatran or warfarin. The results will be presented on December 8.

Detailed information regarding the data presentations include:

  • Saturday, December 8, Oral Sessions
    • Management and Outcomes of Major Bleeding On Dabigatran or Warfarin (Lead Author: A. Majeed) [Abstract No. 19, 12:00 p.m.]
    • Benefit of Extended Maintenance Therapy for Venous Thromboembolism with Dabigatran Etexilate Is Maintained Over 1 Year of Post-Treatment Follow-up (Lead Author: S. Schulman) [Abstract No. 21, 12:30 p.m.]
    • Reversal of Dabigatran's Anticoagulant Activity in the Monkey by a Specific Antidote and Pharmacokinetic and Pharmacodynamic Modeling (Lead Author: J. Toth) [Abstract No. 22,12:45 p.m.]
  • Saturday, December 8, Poster Session
    • Real-World Study of Dabigatran Etexilate for Thromboprophylaxis in Over 5000 Hip or Knee Replacement Patients: Favourable Safety Profile in Subgroups with Different BMI, Renal Function and Age (Lead Author: N. Rosencher) [Abstract No. 1160, 5:30 p.m.7:30 p.m.]
  • Sunday, December 9, Poster Sessions
    • Epidemiological Data On the Incidence of Co-Morbidities and Co-Medications in Patients Undergoing Total Hip or Knee Replacement Surgery: Real-World Study and Phase III Clinical Trials (Lead Author: N. Rosencher) [Abstract No. 2269, 6:00 p.m.8:00 p.m.]
    • Acceleration of Dabigatran Elimination by Activated Charcoal Perfusion and Hemodialysis in a Pig Model (Lead Author: J. Lange) [Abstract No. 2272, 6:00 p.m.8:00 p.m.]
  • Monday, December 10, Health Services and Outcomes Research Session
    • Persistence Among Patients with Non-Valvular Atrial Fibrillation Beginning Dabigatran or Warfarin (Lead Author: K. M Francis) [Abstract No. 365, 8:00 a.m.]
  • Monday, December 10, Poster Session
    • In Vitro Characterization, Pharmacokinetics and Reversal of Supratherapeutic Doses of Dabigatran-Induced Bleeding in Rats by a Specific Antibody Fragment Antidote to Dabigatran (Lead Author: J. van Ryn) [Abstract No. 3418, 6:00 p.m.8:00 p.m.]

About Pradaxa® (dabigatran etexilate mesylate) Capsules

Indications and Usage

Pradaxa® (dabigatran etexilate mesylate) capsules is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

IMPORTANT SAFETY INFORMATION ABOUT PRADAXA

CONTRAINDICATIONS

PRADAXA is contraindicated in patients with active pathological bleeding and patients with a known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock) to PRADAXA.

WARNINGS & PRECAUTIONS

Risk of Bleeding

  • PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.  Promptly evaluate any signs or symptoms of blood loss, such as a drop in hemoglobin and/or hematocrit or hypotension.  Discontinue PRADAXA in patients with active pathological bleeding. 
  • Risk factors for bleeding include medications that increase the risk of bleeding (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs).  PRADAXA's anticoagulant activity and half-life are increased in patients with renal impairment.
  • A specific reversal agent for dabigatran is not available.  Dabigatran can be dialyzed (removal of about 60% of drug over 2-3 hours) but data supporting this is limited. Activated prothrombin complex concentrates, recombinant Factor VIIa, or concentrates of factors II, IX or X may be considered but their use has not been evaluated.  Protamine sulfate and vitamin K are not expected to affect dabigatran anticoagulant activity.  Consider administration of platelet concentrates where thrombocytopenia is present or long-acting antiplatelet drugs have been used.

Temporary Discontinuation of PRADAXA

Discontinuing PRADAXA for active bleeding, elective surgery, or invasive procedures places patients at an increased risk of stroke.  Minimize lapses in therapy.

Effect of P-gp Inducers & Inhibitors on Dabigatran Exposure

The concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided.  P-gp inhibition and impaired renal function are major independent factors in increased exposure to dabigatran.  Concomitant use of P-gp inhibitors in patients with renal impairment is expected to increase exposure of dabigatran compared to either factor alone.

  • For patients with moderate renal impairment (CrCl 30-50 mL/min), consider reducing the dose of PRADAXA to 75 mg twice daily when dronedarone or systemic ketoconazole is coadministered with PRADAXA.
  • For patients with severe renal impairment (CrCl 15-30 mL/min), avoid concomitant use of PRADAXA and P-gp inhibitors.

ADVERSE REACTIONS

In the pivotal trial comparing PRADAXA to warfarin, the most frequent adverse reactions leading to discontinuation of PRADAXA were bleeding and gastrointestinal (GI) events. PRADAXA 150 mg resulted in a higher rate of major GI bleeds and any GI bleeds compared to warfarin. In patients ≥75 years of age, the risk of major bleeding may be greater with PRADAXA than with warfarin. Patients on PRADAXA 150 mg had an increased incidence of GI adverse reactions.  These were commonly dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including GERD, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis, and GI ulcer).  Drug hypersensitivity reactions were reported in <0.1% of patients receiving PRADAXA.

Other Measures Evaluated

In the pivotal trial, a higher rate of clinical myocardial infarction was reported in patients who received PRADAXA (0.7 per 100 patient-years for 150 mg dose) than in those who received warfarin (0.6).

NSAIDs=non-steroidal anti-inflammatory drugs.

CrCl=creatinine clearance.

GERD=gastroesophageal reflux disease.

For full PRADAXA prescribing information, please visit www.pradaxa.com or contact Boehringer Ingelheim's Medical and Technical Information Unit at 1-800-542-6257.

About the Boehringer Ingelheim Cares Foundation Patient Assistance Programs

For more than 125 years, Boehringer Ingelheim has been focused on improving the lives of patients. In keeping with the company commitment to do the most good for the most people, Boehringer Ingelheim works hard to ensure its medicines are accessible to everyone who needs them, including senior citizens and families on limited incomes. The Boehringer Ingelheim Cares Foundation Patient Assistance Programs (BI-PAP) make Boehringer Ingelheim medicines available free of charge to patients who are without pharmaceutical insurance coverage, and who meet certain household income levels.

About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

In 2011, Boehringer Ingelheim achieved net sales of about $17.1 billion (13.2 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

PRADAXA® is a registered trademark of Boehringer Ingelheim Pharma GmBH and Co. KG and used under license.

RE-LY® is a registered service mark of Boehringer Ingelheim International GmBH and used under license.

 

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

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